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Recruiting NCT04556214

Liver Transplantation for Non-Resectable Intrahepatic Cholangiocarcinoma: a Prospective Exploratory Trial (TESLA Trial)

No phase Interventional Intrahepatic Cholangiocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Liver Transplant.
Who it may be relevant to
Registry conditions: Intrahepatic Cholangiocarcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The study will investigate whether liver transplantation provides increased survival, low side effects and good quality of life in patients with bile duct cancer where the tumor cannot be removed by normal surgery. Analyzes of blood and tissue samples from the tumor will be investigated to see if the analyzes can indicate who may have recurrence of the disease after liver transplantation. Furthermore, the effect of chemotherapy on normal liver and tumor tissues in the liver that are removed during transplantation will be investigated..

Interventions

  • Procedure Liver Transplant
    Liver Transplant

Primary outcome measures

  • Overall Survival (OS) [Time frame: From screening and until 36 months after inclusion]
Secondary outcome measures (7)
  • Overall Survival from time of relapse [Time frame: From time of relapse and until 36 months after inclusion]
  • Disease free survival [Time frame: After liver transplantation and up 10 years after liver transplantation]
  • Start of new treatment/Change of strategy [Time frame: Immediately after liver transplatation to start of new treatment]
  • Time to decrease in physical function and global health score [Time frame: Up to 10 years after liver transplantation]
  • Liver transplant Complication [Time frame: Up to 90 days after liver transplantation]
  • Number of Participants Developing other Malignancies [Time frame: Up to 10 years after liver transplantation]
  • Survival in relation to biological markers [Time frame: After Liver Transplant until 10 years after liver transplantation]

Eligibility criteria

Inclusion criteria

  • Histologically verified diagnosis of Intrahepatic Cholangiocarcinoma (iCCA)
  • First time iCCA or liver only recurrence after previous liver resection for iCCA
  • Disease deemed not eligible for liver resection based on tumor location or underlying liver dysfunction
  • No vascular invasion, extrahepatic disease, or lymph node involvement detected on imaging
  • No signs of extrahepatic metastatic disease according to positron emission computed tomography (PET-CT) scan
  • Patient must be accepted for transplantation before progressive disease on chemotherapy.
  • Twelve months or more time span from the diagnosis of iCCA and date of being listed for liver transplantation
  • No signs of extrahepatic metastatic disease according to CT or magnetic resonance (MR) scan within 4 weeks prior to the faculty meeting at the transplant unit
  • At least 18 years of age
  • Good performance status, Eastern Cooperative Oncology Group (ECOG) 0 or 1
  • Signed informed consent and expected cooperation of the patients for the treatment and follow up
  • Received at least 6 months of chemotherapy or locoregional therapy

Exclusion criteria

  • Major vascular involvement of the tumor
  • Perforation of the visceral peritoneum
  • Weight loss >15% the last 6 months
  • Patient BMI > 30
  • Other malignancies, except curatively treated more than 5 years ago without relapse
  • Known history of human immunodeficiency virus (HIV) infection
  • Prior history of solid organ or bone marrow transplantation
  • Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  • Known hypersensitivity to rapamycin
  • Prior extrahepatic metastatic disease
  • Women who are pregnant or breast feeding
  • Any reason why, in the opinion of the investigator, the patient should not participate

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

Norway · 1 center
  • Oslo University Hospital — Oslo

Publications

  • Achurra P, Fernandes E, O'Kane G, Grant R, Cattral M, Sapisochin G. Liver transplantation for intrahepatic cholangiocarcinoma: who, when and how. Curr Opin Organ Transplant. 2024 Apr 1;29(2):161-171. doi: 10.1097/MOT.0000000000001136. Epub 2024 Jan 23. PMID 38258823

Identifiers

NCT: NCT04556214 · TESLA trial

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗